BEUDAMED
    FDA Recall Terminated

    ENTrak Plus Navigation and Visualization System

    Recall: Z-0813-05 · Initiated July 12, 2004

    Recall

    Recall Number
    Z-0813-05
    Event Number
    31057
    Firm
    GE OEC Medical Systems, Inc
    FEI Number
    1720753
    Product Code
    LLZ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 12, 2004
    Posted
    May 11, 2005
    Terminated
    August 2, 2011
    Address
    384 Wright Brothers Dr, Salt Lake City, UT, 84116-2862

    Description

    ENTrak Plus Navigation and Visualization System

    Reason

    Navigation inaccuracy may result if the headset registration method is used with the Axcess System Kit.

    Action

    Customers were notified by letter on 07/12/04.

    Distribution

    Domestic distribution: VA, CT, KY, NJ, LA, PA, TN, OK, CA. Foreign distribution to Germany. There were no military or VA facilities.

    Quantity

    2 kits